Perspectives in Clinical Research最新文献

{"title":"A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials","authors":"Sowparnika Treasa Sabu, Shravan Venkatraman, Jerin Jose Cherian, Saibal Das, Monika Pahuja, Tulsi Adhikari, Shoibal Mukherjee, Nabendu Sekhar Chatterjee, Nilima Arun Kshirsagar","doi":"10.4103/picr.picr_124_23","DOIUrl":"https://doi.org/10.4103/picr.picr_124_23","url":null,"abstract":"Abstract Aim: This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. Materials and Methods: The data were extracted from the Clinical Trials Registry – India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug–drug interaction studies) were excluded from the study. Results: A total of 1891 trials were retrieved and 220 were included in the analysis. Most of the investigational products were drugs (55%) followed by vaccines (38.2%). The most common therapeutic class of drugs was cancer chemotherapy (19.8%), followed by antimicrobial chemotherapy and endocrinology (18.2% each). The most common vaccine was the influenza vaccine (21.4%), followed by the measles–mumps–rubella vaccine (15.5%). The pharmaceutical industry was the predominant sponsor for most (91%) of the Phase 1 trials. Of the top five sites where most of the Phase 1 trials were conducted, three were private nonacademic centers (cumulatively 31%) and two were tertiary care medical colleges (cumulatively 9%). Conclusion: Phase 1 clinical trials seem to be conducted in India predominantly with industry sponsorship. There is a need to have an alternate ecosystem to take forward molecules that do not receive adequate attention from the industry and molecules that are of national health priority other than areas such as chemotherapy, antimicrobials, and endocrinology. The Indian Council of Medical Research is setting up Phase 1 clinical trial capacity for molecules that predominantly may arise from nonindustry channels.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials","authors":"Deepa Chodankar, Tapan K. Raval, Jeyaseelan Jeyaraj","doi":"10.4103/picr.picr_219_22","DOIUrl":"https://doi.org/10.4103/picr.picr_219_22","url":null,"abstract":"Abstract Decentralized clinical trials (DCTs) are gaining momentum in clinical research as these studies can be executed remotely through telemedicine and mobile/local health-care providers. The COVID-19 pandemic has further accelerated advances and adoption in this area. In the past few years, there has been significant development and growth in the use of remote data that are electronically transmitted from a clinical trial (CT) participant, from outside the clinical setting, to a data repository. Such data may include laboratory data, safety data, or outcome measures reported by the participant, the clinician or the observer. Similarly, wearable health monitoring devices are being increasingly used in health-care and CT settings. Digital biomarkers, which can support continuous measurement of physiologic parameters outside the physical confines of the clinical environment, are also creating new and improved opportunities for patient care and biomedical research, enabling remote monitoring and DCTs. There are several benefits to using remote data capture, wearables, and digital biomarkers in clinical health-care research; however, several questions and challenges still need to be addressed. In an effort to understand the adoption of these technologies in DCTs, and the challenges therein, the authors of this workstream conducted an online survey of clinical research stakeholders across India and reviewed 80 responses. The review article summarizes the key findings from this online survey.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135922796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the trend of use of qualitative methods in randomized controlled trials.","authors":"S R Disha, K Merin Eldhose, Yashashri Shetty","doi":"10.4103/picr.picr_131_22","DOIUrl":"10.4103/picr.picr_131_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adherence to Consolidated Health Economic Evaluation Reporting Standards guidelines for published pharmacoeconomic studies in PubMed-indexed medical journals over a year (2021-2022).","authors":"Miteshkumar Maurya, Renuka Munshi","doi":"10.4103/picr.picr_7_23","DOIUrl":"10.4103/picr.picr_7_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual clinical trials.","authors":"Priya Ranganathan, Rakesh Aggarwal, C S Pramesh","doi":"10.4103/picr.picr_184_22","DOIUrl":"10.4103/picr.picr_184_22","url":null,"abstract":"<p><p>Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs. The use of such trials increased manifold during the COVID-19 pandemic and is likely to continue in the future.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prescribing patterns and pharmacoeconomic analysis of antihypertensive drugs in South Indian population: A cross-sectional study.","authors":"S Shanmugapriya,&nbsp;Saravanan Thangavelu,&nbsp;Aashiq Ahamed Shukkoor,&nbsp;P Janani,&nbsp;R Monisha,&nbsp;Varsha Elsa Scaria","doi":"10.4103/picr.picr_122_22","DOIUrl":"10.4103/picr.picr_122_22","url":null,"abstract":"<p><strong>Background: </strong>Global evidence-based recommendations for hypertension management are periodically updated, and ensuring adherence to the guidelines is imperative. Furthermore, the current high prevalence of hypertension effectuates a high health-care cost.</p><p><strong>Purpose: </strong>To evaluate the prescribing patterns of antihypertensive drugs and other factors affecting blood pressure (BP) with the objective of assessing the proportion of patients achieving the target BP and to perform a pharmacoeconomic analysis in a South Indian population.</p><p><strong>Materials and methods: </strong>In a cross-sectional study, 650 patients previously diagnosed with hypertension and already on treatment with one or more drugs were included. A prospective interview of patients was done using a prevalidated questionnaire on various factors in BP control. Prescribing patterns and pharmacoeconomic analyses, namely, cost acquisition, cost of illness, and cost-effectiveness analyses were carried out.</p><p><strong>Results: </strong>Of 650 subjects, 257 (39.54%) achieved the target BP, while 393 (60.46%) did not. A significant association of age, occupational status, monthly family income, and area of residence in addition to physical activity and diet scores, with achieving target BP was noted. A significantly higher cost of anti-hypertensive drug treatment in achieving target BP (<i>P</i> = 0.02) was observed. Among patients who achieved target BP, 37.35% were on monotherapy and 48.25% on multiple drug therapy compared to 46.31% and 35.62%, respectively, in patients who did not. Average cost-effectiveness ratio were found to be Rs. 20.45 and Rs. 57.27, respectively, for single and multiple drug therapies, with incremental cost-effectiveness of Rs. 194.14 per additional patient treated with multiple free drug combinations.</p><p><strong>Conclusion: </strong>This study identified the anti-hypertensive prescribing pattern and provided insight into the various pharmacoeconomic factors that play a significant role in attaining target BP in the treated population.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f2/c8/PCR-14-114.PMC10405530.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9965186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical studies with Cannabis in India - A need for guidelines for the investigators and ethics committees.","authors":"Prakash Nayak,&nbsp;Gouri Pantvaidya,&nbsp;Priya Ranganathan,&nbsp;Sabita Jiwnani,&nbsp;Shalaka Joshi,&nbsp;Nithya Jaideep Gogtay","doi":"10.4103/picr.picr_159_22","DOIUrl":"10.4103/picr.picr_159_22","url":null,"abstract":"<p><p>Cannabis is one of the world's oldest cultivated plants and the most commonly used recreational drug worldwide. The plant relevant for medicinal use is <i>Cannabis</i> <i>sativa</i> that has two pharmacologically active ingredients - delta-9-tetrahydrocannabinol that is psychoactive and cannabidiol that does not have psychotropic activity. The policy tapestry of Cannabis has undergone a significant change in the past few decades worldwide. Different countries have diverse policies, ranging from classifying use of Cannabis as illicit, to legalization of its use, both for medicinal and recreational purposes. Cannabis products are approved for use, for instance, in multiple sclerosis and Dravet syndrome (US Food Drug and Administration). Against this backdrop, we find that the knowledge foundations for use of Cannabis in clinical trials in India are still evolving. Conducting ethical research within a clinical trials framework is essential to understand dosing, formulation, shelf life, drug-drug interaction, tolerability, and safety before establishing its utility for various indications. In the absence of guidelines or a regulatory framework for conduct of these studies, the various Institutional Ethics Committees (IECs), which are responsible for reviewing projects related to Cannabis, face unique challenges with respect to the basic requirements. The principal investigators (PIs) are equally strained to find local guidance, recommendations, and literature in support of their application to the respective IEC, thus leading to an impasse and delay in initiating the proposed clinical studies with Cannabis. The present article addresses considerations, questions, and issues that affect the conduct of these clinical studies and recommends mandatory documents and some suggested guidelines for use by both PIs and IECs to take studies with Cannabis forward until such time that an interdisciplinary regulatory framework is firmed up by regulatory authority.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9c/e0/PCR-14-146.PMC10405537.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9956237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengthening postapproval oversight in research ethics committees: Challenges and solutions.","authors":"Yashashri Chandrakant Shetty,&nbsp;Rajmohan Seetharaman","doi":"10.4103/picr.picr_151_23","DOIUrl":"10.4103/picr.picr_151_23","url":null,"abstract":"The establishment of robust ethical review processes is crucial to safeguard the rights and well-being of human subjects participating in research studies. The aftermath of historical scandals, such as the Tuskegee study, led to the development of ethical guidelines such as the Belmont Report, emphasizing the need for Institutional Review Boards and Ethics Committees. Over time, these bodies have become the golden rule for conducting human subject research, ensuring a thorough review process before initiation.[1]","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c7/6d/PCR-14-105.PMC10405534.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9956241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunomodulatory effect of a proprietary polyherbal formulation on healthy participants: A single- blind, randomized, placebo- controlled, exploratory clinical study.","authors":"Suresh Khadke,&nbsp;Poonam Gupte,&nbsp;Akanksha Mourya,&nbsp;Amit Yadav,&nbsp;Sarika Mane,&nbsp;Asavari Joshi,&nbsp;Madhavi Mahajan,&nbsp;Manisha Mishra,&nbsp;Supriya Bhalerao","doi":"10.4103/picr.picr_100_22","DOIUrl":"10.4103/picr.picr_100_22","url":null,"abstract":"<p><strong>Context: </strong>Clinical study for immunity.</p><p><strong>Aims: </strong>The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic.</p><p><strong>Settings and design: </strong>Single-blind, randomized, placebo-controlled, exploratory study in institutional setting.</p><p><strong>Materials and methods: </strong>Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months. Major assessment variables included peak expiratory flow rate (PEFR), questionnaire-based immune status, perceived stress, and quality of life (QOL) with immune-specific cell counts (CD4+, CD8+), cytokines (interferon gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], interleukin 10 [IL-10]), and oxidative stress in red blood cells (RBCs) (malondialdehyde (MDA), glutathione peroxidase [GPx]), done at day 60.</p><p><strong>Statistical analysis used: </strong>Mean ± standard deviation and paired/unpaired <i>t-</i>test for parametric data analysis while median (range) and Wilcoxon Rank sum test/Mann-Whitney test for nonparametric data analysis, were done. Categorical data was analyzed using Chi-square test. GraphPad InStat software, version 9 was used with <i>p</i> < 0.05, as the level of statistical significance.</p><p><strong>Results: </strong>Of 52 recruited, 28 individuals completed the study. PPHF significantly increased PEFR, improved immune status along with QOL compared to baseline. It also decreased perceived stress from moderate and severe grade to mild. Serum IFN-γ levels remained almost constant post-PPHF treatment. PPHF significantly decreased MDA and increased GPx in RBCs. Significant decrease and increase in TNF-α and IL-10, respectively, were seen in PPHF group. The safety parameters post-PPHF treatment remained within normal reference ranges.</p><p><strong>Conclusions: </strong>PPHF is an efficacious and safe formulation with immunomodulatory potential.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/8d/PCR-14-130.PMC10405535.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps?","authors":"Wen-Yi Shau,&nbsp;Sajita Setia,&nbsp;Salil Shinde,&nbsp;Handoko Santoso,&nbsp;Daniel Furtner","doi":"10.4103/picr.picr_193_22","DOIUrl":"10.4103/picr.picr_193_22","url":null,"abstract":"<p><p>Evidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however, if the influence of external factors or confounders is not effectively managed, the cause-and-effect relationship and internal validity may be challenged, resulting in flawed results. The collection of quality real-world evidence (RWE) is crucial in Asia as there is often an underrepresentation of Asian populations in RCTs. In addition, few countries in Asia are catching up with the Western world in issuing practical foundational principles and guidance for conducting and adopting evidence for regulatory and reimbursement decisions. However, privacy and data protection laws are generally lagging behind technological developments in electronic medical records. While leveraging RWE in clinical and regulatory decision-making holds excellent potential, collective efforts across industry, governments, and research institutions are required for generating standardized practices and building capabilities for developing fit-for-purpose RWE in Asia.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c9/3a/PCR-14-108.PMC10405531.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}